Overview
SCINC is an adaptive design Master protocol that seeks to determine if there is "sufficient promise" of beneficial effect of treatment combinations to enhance motor recovery in pre-specified strata of people with a spinal cord injury.
Description
SCINC utilises an adaptive design with interim analyses to assess whether a given intervention is futile or shows a "signal of benefit" within an appendix-specific study. The SCINC Master Protocol describes trial procedures, data collection, data monitoring, follow-up visits, and safety procedures that will be employed in all study-specific Appendices. The study-specific Appendix is a Bayesian optimised phase IIA trial, operating under the overarching SCINC Master Protocol. The first study-specific appendix is: Restoration of Respiratory and Upper Limb function after cervical spinal cord Injury (RRULI): Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET). The RULLI: Appendix 1 (TIH + ET) aims to determine if ET plus TIH in people with chronic tetraplegia is a therapy with sufficient promise to test in a Phase IIb/III trial; considering feasibility, safety and efficacy. As new interventions are put forth, they will be added to the Master Protocol as a new Appendix. This Master Protocol describes trial procedures, data collection, data monitoring, follow-up visits, and safety procedures that will be employed in all study-specific Appendices. Each study-specific Appendix will have a process evaluation protocol.
Eligibility
SCINC Inclusion Criteria:
- Person with SCI
SCINC Exclusion Criteria:
- Proven contraindication to intervention
RRULI: Appendix 1 (TIH + ET) study-specific inclusion criteria:
- Adults > 18 years of age
- Able to independently ventilate
- Chronic SCI (>1 years post-injury or impairment onset)
- Tetraplegia (C2-T1 level of injury)
- Evidence of motor incomplete paralysis in the upper limb below the neurological level of injury
- Have a documented management plan for their AD if it occurs.
RRULI: Appendix 1 (TIH + ET) study-specific exclusion criteria:
- Pregnancy
- Medical instability, including current or recent (within the previous 6 weeks) infection or inflammation
- Current or recent (within the previous 6 weeks) pressure ulcers or cutaneous lesions
- Poorly controlled diabetes
- An episode of AD in the previous 6 months that required medical intervention to resolve
- Significant other neurological, psychiatric, pulmonary, cardiovascular, orthopaedic, or oncological conditions.
- Currently taking part in another clinical trial
- Upper limb contracture